FLORINA Tablet 21's

INTRODUCTION ABOUT FLORINA TABLET

FLORINA TABLET is a combination of Levonorgestrel and Ethinylestradiol which
belongs to the group of medicines called Hormonal Contrace
used as a contrace
acne vulgaris among adult women (aged 18 years or above) who wish to take oral
contrace

Before taking FLORINA TABLET inform your doctor if you have any lung, liver,
kidney or heart problems. You must also inform your doctor if you have asthma,
diabetes, high blood pressure, high blood cholesterol levels, migraine, obesity,
epilepsy or depression as a precaution.

FLORINA TABLET is strictly not recommended for use in patients with breast
cancer, cervical cancer or liver cancer. It is also not suitable for use in
patients with depression, blood clots, stroke or any problems in blood
circulation.

FLORINA TABLET is not intended for use in pregnant women, in children who have
not attained puberty and among elderly women who have reached menopause. It is
also not recommended for use in breastfeeding women and in women (aged above 35
years) who have the habit of smoking.

The most common side effects of taking FLORINA TABLET are vaginal infections or
inflammation, vaginal discharge, unusual spotting or bleeding, breast
tenderness, milk discharge from breasts, mood changes, low sex drive and changes
in body weight. Consult your doctor if any of these side effect worsens.

USES OF FLORINA TABLET

• Used as a contrace
• Manage acne

HOW FLORINA TABLET WORKS

FLORINA TABLET is a contrace
suppressing ovulation (release of a mature egg from ovary). It can also reduce
the thickness of the inner lining of uterus which makes it not suitable for the
foetus to implant and grow.

Additionally, it can alter the thickness of the cervical mucus which makes it
difficult for the sperm to enter the uterus and fertilize the egg. As a result,
they create an unfavourable environment for a successful pregnancy.

It can also reduce the production of male sex hormones (testosterone) in the
body. This helps in reducing excess oil production in the skin which in turn
reduces hormonal acne.

DIRECTIONS FOR USE

Take FLORINA TABLET strictly as advised by your physician. Swallow FLORINA
TABLET with a glass of water. Do not crush or chew the medicine. FLORINA TABLET
can be taken with or without meals.

Do not miss any dose of FLORINA TABLET in between the therapy, as it may reduce
its effectiveness. In case if you have missed a dose of FLORINA TABLET, take it
as soon as you remember. Avoid taking a double dose of FLORINA TABLET to
compensate the missed dose.

Your doctor will decide the correct dose and duration of therapy for you
depending upon your age, body weight and health condition.

SIDE EFFECTS OF FLORINA TABLET

COMMON

• vaginal infection, itching or inflammation
• discharge from vagina
• changes in body weight
• changes in mood (mood swings)
• depression
• changes in sex drive
• headache, tiredness
• feeling nervous
• nausea, vomiting, stomach pain
• unusual spotting or bleeding
• breast pain or tenderness
• milk discharge from breasts
• heavy periods or lack of periods
• swelling of body parts (edema)

UNCOMMON

• changes in blood cholesterol levels
• changes in appetite
• increase in blood pressure
• flatulence (bloating)
• skin rashes, dark patches on the skin
• hirsutism (abnormal hair growth in the body)
• hair loss

RARE

• decrease in serum folate levels
• unable to wear contact lenses
• cholestatic jaundice

Stop taking FLORINA TABLET and contact your doctor immediately if you experience
any of the following side effects:

• signs of allergic reactions (such as swelling of the face, lips, mouth, tongue or throat causing difficulty in breathing or swallowing)
• signs of breast cancer (presence of lumps in breast, skin dimpling in breast and changes in the nipple)
• signs of cervical cancer (smelly or bloody discharge from vagina, unusual vaginal bleeding, pelvic pain and painful sex)
• signs of severe liver problems (such as severe pain in your upper abdomen, yellow skin or eyes, itching in the whole body)
• signs of blood clot in the legs (such as swelling of the affected leg or foot accomp
• signs of blood clot in the lungs (such as sudden unexplained breathing difficulty, rapid heart rate, sharp chest pain, severe light headedness or dizziness)
• signs of blood clot in the eyes (such as sudden loss of vision or painless blurring of vision)
• signs of heart attack (chest pain, pressure, heaviness in the chest, abnormal heartbeat, extreme weakness, anxiety or shortness of breath, sweating, nausea, vomiting or dizziness)
• signs of stroke (sudden weakness or numbness of the face, arm or legs, especially on one side of the body, confusion, trouble in speaking or understanding, walking, dizziness, loss of balance, fainting with or without seizure)
• feeling depressed with thoughts of killing or harming yourself

HOW TO MANAGE SIDE EFFECTS

Headache:

Rest and relax. Keep yourself hydrated by drinking plenty of fluids such as
water or electrolytes. Applying a pain-relieving balm on your forehead can be
beneficial. Do not consume excessive alcohol, as it could aggravate your
headache. Consult your doctor if your headache worsens.

Nausea and Vomiting:

Take FLORINA TABLET with or just after meals. Stick to simple meals. Avoid
eating oil rich or spicy foods. Consult your doctor if your nausea worsens.

WARNING & PRECAUTIONS

!### PREGNANCY

FLORINA TABLET is not recommended for use in pregnant women and in women who
think that they might be pregnant. It is also not recommended for use in women
who have or ever had jaundice due to pregnancy. It should be used with
caution in pregnant women with a previous history of herpes gestationis (an
autoimmune skin disease). Therefore, consult your doctor before taking it.

!### BREASTFEEDING

FLORINA TABLET is not recommended for use in breast-feeding women. Therefore,
consult your doctor before taking it.

!### DRIVING AND USING MACHINES

FLORINA TABLET has negligible effects on driving or handling heavy tools or
machines. However, do not drive or handle any heavy machines if your ability is
affected by FLORINA TABLET.

!### ALCOHOL

Avoid consum

!### KIDNEY

FLORINA TABLET is not recommended for use in patients with kidney diseases (such
as kidney failure). It should be used with caution in patients with other kidney
problems. Therefore, consult your doctor before taking it.

!### LIVER

FLORINA TABLET is not recommended for use in patients who have or every had
liver diseases (such as liver tumours). It should be used with caution in
patients with other liver or gall bladder problems (such as jaundice, gall
stones).Therefore, consult your doctor before taking it.

!### ALLERGY

Do not take FLORINA TABLET if you are allergic toLevonorgestrel or
Ethinylestradiol.

!### LUNGS

FLORINA TABLET is not recommended for use in patients who have blood clots in
the lungs (pulmonary embolism). It should be used with caution in patients with
asthma. Therefore, consult your doctor before taking it.

!### HEART DISEASE

FLORINA TABLET is not recommended for use in patients who have or ever had heart
diseases (such as coronary artery disease, heart attack, angina, valvular heart
disease or arrhythmias). It should be used with caution in patients with other
heart problems. Therefore, consult your doctor before taking it.

OTHERS

FLORINA TABLET is not recommended for use if you:

• have or had blood clots in legs (deep vein thrombosis) or eyes (retinal thrombosis)
• have any type of blood clotting disorders (such as APC resistance, protein C deficiency, protein S deficiency, antithrombin-III deficiency, antiphospholipid antibodies in blood which cause immediate blood clots)
• have any pre planned surgery
• have severe diabetes with damage in blood vessels
• have uncontrolled high blood pressure
• have high blood cholesterol and triglyceride levels
• have or ever had migraine headaches
• have or ever had or at risk of developing breast cancer or cancers in genital organs
• have hyperhomocysteinaemia (an increase in the levels of an amino acid called homocysteine in blood)
• have unexplained bleeding from the vagina
• have pancreatitis (severe inflammation of the pancreas)
• have hepatitis C infection (a type of viral infection affecting the liver)
• have adrenal insufficiency (when body does not produce enough aldosterone hormone)
• are aged above 35 years and have a habit of smoking
• have stroke or problems in blood circulation
• have reached menopause

Before taking FLORINA TABLET inform your doctor if you:

• have family history of breast cancer
• have hypertension
• have depression
• have diarrhea/vomiting
• have otosclerosis (abnormal bone growth in the ears)
• have Crohn’s disease or ulcerative colitis (chronic inflammatory bowel disease)
• have systemic lupus erythematosus (disease affecting your immune system)
• have haemolytic uraemic syndrome (blood clotting disorder causing kidney failure)
• have sickle cell anaemia (an inherited red blood cell disease)
• have just given birth
• had abortion in the second trimester
• have been bed-ridden or immobile for prolonged period
• have an inflammation in the veins under the skin (superficial thrombophlebitis)
• have varicose veins (enlarged or twisted veins)
• have epilepsy
• are obese
• have porphyria (a rare inherited blood disorder)
• have abnormal body movements (chorea)
• have multiple sclerosis (an autoimmune disease, causing nerve damage)
• have tetany (involuntary muscle contractions)
• have a history of chloasma gravidarum (dark patches on the skin) in previous pregnancies
• are due to have a lab test

Use in Paediatrics:

FLORINA TABLET is not recommended for use in children and in adolescent girls
aged below 18 years. It is also not intended for use in female children who have
not attained puberty. Therefore, consult your doctor before taking it.

Use in Geriatrics:

FLORINA TABLET is not indicated for use in elderly women. Therefore, consult
your doctor before taking it.

INTERACTIONS

A. Drug - Drug interactions:

Before taking FLORINA TABLET, inform your doctor if you are taking any of the
following medicines such as:

• medicines used to manage epilepsy (Ex. primidone, phenytoin, topiramate, phenobarbital, carbamazepine, oxcarbazepine, felbamate, lamotrigine)
• medicines used to manage tuberculosis (Ex. rifampicin, rifabutin)
• dexamethasone (a medicine used to manage asthma or autoimmune diseases)
• atorvastatin (a medicine used to manage high blood cholesterol levels)
• modafinil (a medicine used to reduce sleep in narcolepsy)
• troleandomycin (a medicine used to manage bacterial infections)
• ascorbic acid (a vitamin C supplement)
• medicines used to manage HIV infection (Ex. ritonavir, nevirapine, efavirenz)
• medicines used to manage fungal infections (Ex. fluconazole, griseofulvin)
• St. John’s wort (an herbal remedy used to manage mental illness)
• medicines used to manage graft rejection during organ transplants (Ex. cyclosporin)
• theophylline (used to manage breathing problems)
• flunarizine (a medicine used to manage vertigo)
• medicines used to manage hepatitis C infections (Ex. ombitasvir, paritaprevir, ritonavir and dasabuvir)
• medicines used to relive pain (Ex. ibuprofen, aceclofenac, phenylbutazone, paracetamol)
• heparin (a medicine used to manage blood clots)

Overdosage:

If you or anyone else accidentally took more FLORINA TABLET, consult your doctor
immediately or visit the nearby hospital. Symptoms of overdose might include
nausea, vomiting, breast tenderness, dizziness, stomach pain, fatigue and
withdrawal bleeding.

SYNOPSIS

Drug	:	Levonorgestrel, Ethinylestradiol
Pharmacological Category	:	Synthetic Progestins, Estrogens
Therapeutic Indication	:	Contrace
Dosage Forms	:	Tablet

MORE INFORMATION

• Keep FLORINA TABLET out of reach of children
• Store FLORINA TABLET at room temperature

FAQs ABOUT FLORINA TABLET

Can I stop taking FLORINA TABLET once my acne gets reduced?

No. Do not stop taking FLORINA TABLET unless your doctor advises you to do so
because sudden termination of FLORINA TABLET will not provide any expected
results. Acne caused by hormonal changes may require long term management.
Kindly use FLORINA TABLET as advised by the doctor.

Can FLORINA TABLET be used to manage acne in men?

No. FLORINA TABLET is used to reduce acne only in adult females (aged 18 years
or above) who wish to take oral contrace
men. Kindly consult your doctor before taking.

How and when should I take FLORINA TABLET for acne and PMDD?

Take FLORINA TABLET strictly as advised by your physician. Swallow FLORINA
TABLET with a glass of water. Do not crush or chew the medicine. FLORINA TABLET
can be taken with or without meals.

Is it safe to take FLORINA TABLET immediately after delivery?

No. Do not take FLORINA TABLET immediately after delivery. Consult your doctor
before taking because FLORINA TABLET may increase the risk of blood clots in
such patients. It is advisable to take FLORINA TABLET only after 4 weeks
post-delivery. However, consult your doctor before taking it.

Can FLORINA TABLET be used in children?

FLORINA TABLET is not recommended for use in children and in adolescent girls
aged below 18 years. It is also not intended for use in female children who have
not attained puberty. Therefore, consult your doctor before taking it.

Can FLORINA TABLET be used in post-menopausal women?

FLORINA TABLET is a contrace
intended for use in post-menopausal women.

Can FLORINA TABLET be used to manage acne in pregnant women?

FLORINA TABLET is strictly not recommended for use in pregnant women and in
women who think that they might become pregnant. If you become pregnant
accidentally while undergoing therapy with FLORINA TABLET, stop taking FLORINA
TABLET and inform your doctor immediately.

Do FLORINA TABLET cause cancer?

Studies have shown that FLORINA TABLET may cause breast cancer in some
individuals. This is predominant particularly in patients who had or have a
family of breast cancer. Therefore, inform your doctor if you or anyone of your
family member has breast cancer before taking FLORINA TABLET as a precaution.
Also, during therapy with FLORINA TABLET, your doctor would periodically monitor
your breasts and overall health to avoid the risk of breast cancer. The risk of
breast tumours gradually decreases after stopping FLORINA TABLET therapy.

Can the use of FLORINA TABLET cause unexpected bleeding?

Yes. Irregular vaginal bleeding or spotting may occur while you are taking
FLORINA TABLET. Such bleeding may be temporary and usually does not indicate any
serious problems. However, consult your doctor if you experience prolonged
painful bleeding.

Can FLORINA TABLET cause abortion?

FLORINA TABLET is a contrace
fertilization. It is not capable for causing abortion.

Can the use of FLORINA TABLET cause depression?

Yes. FLORINA TABLET may make you feel depressed. This is because FLORINA TABLET
works by controlling the hormones which can exerts its influence on the mood and
mental health. If you feel depressed or have thoughts of harming or killing
yourself, consult your doctor immediately.

What to do if I forgot to take FLORINA TABLET?

If you have missed a dose of FLORINA TABLET, take proper safety measures such as
usage of condoms to avoid pregnancy. Do not take a double dose of this medicine
to compensate the missed ones. Spotting or sudden bleeding can occur in case if
you miss to take FLORINA TABLET.

Will the use of FLORINA TABLET change the length of menstrual cycle?

Yes. There are changes for sudden spotting or vaginal bleeding while taking
FLORINA TABLET. But there has been no reported evidence for long menstrual
cycles.

Will the use of FLORINA TABLET produce complete protection from pregnancy?

Yes. FLORINA TABLET will provide complete protection from pregnancy when all the
doses are taken correctly and regularly. But, if you miss any dose of FLORINA
TABLET, it will not be effective and you may have higher chances of becoming
pregnant.

Is the use of condemn necessary while using FLORINA TABLET?

No. It is not required to use condemn while taking FLORINA TABLET. But if you
miss any dose of FLORINA TABLET, you should use condoms to manage unwanted
pregnancy.

Does FLORINA TABLET stops periods?

No. FLORINA TABLET is a birth control pill used to manage pregnancy. It manages
ovulation and creates unfavourable environment for a fertilized egg to implant
and grow in the uterus. It is not proven to stop periods. However, it may delay
your periods or can cause irregular or scanty periods.

Can FLORINA TABLET cause hair loss?

FLORINA TABLET may cause hair loss in some patients. Consult your doctor if you
experience severe hair loss.

How long can I take FLORINA TABLET?

Take FLORINA TABLET for the stipulated duration prescribed by your doctor. You
may be advised to take FLORINA TABLET every day regularly without fail. One
course would usually last up to 24 days (approximately a month). However, your
doctor will decide the duration of therapy for you. Never miss or skip a dose of
FLORINA TABLET as may reduce the contrace
between the menstrual cycle.

REFERENCES

1. KD. Tripathi. Estrogens, Progestins and Contrace
   Pharmacology. Seventh edition. 2013. Page – 318 & 322.

2. Alaa E A Moubasher, Hisham A Abdel Basset, Asmaa A M Khalil, Eman M K
   Youssef. Levonorgestrel vs combined oral contrace
   female acne and hirsutism. NIH. National Library of Medicine. National Center
   for Biotechnology Information. PMC. . November 2020. [Accessed on 20th
   December 2022].

3. Pfizer Ltd. LOETTEÒ. Levonorgestrel and Ethinyloestradiol Tablets I.P.
   [Revised in January 2022]. [Accessed on 20th December 2022].

4. Central Drugs Standard Control Org
   levonorgestrel + ethinylestradiol tablets IP: Each sugar-coated tablet contains:
   Levonorgestrel IP 150 mcg + ethinylestradiol IP 30 mcg 7 pills of placebo/inert
   tablets. April 2014. Levonorgesterel 100mcg +Ethniyl estradiol IP 20mcg tablet.
   October 2010. [Accessed on 20th December 2022].